- Completed Enrollment in INOpulse® REBUILD Phase 3 trial; Pivotal Top-line Data Expected in Mid-2023
- Signed License Agreement with Baylor BioSciences to Commercialize INOpulse® in
Greater China - Strengthened Balance Sheet Through
$5 Million Registered Direct Offering with Life Sciences-focused Institutional Investor
“We have achieved significant recent progress throughout our business, including advancing the INOpulse® clinical program, enhancing our regulatory and commercial prospects in
Clinical Program Highlights:
Fibrotic Interstitial Lung Disease (fILD)
- REBUILD Phase 3 Study: The Company completed the planned enrollment of 145 patients in the pivotal Phase 3 trial evaluating the safety and efficacy of INOpulse® for the treatment of fILD and anticipates treating the last patients in the second quarter of 2023. The pivotal top-line data readout from patients treated with either INOpulse® at a dose of iNO45 or placebo is expected in mid-2023. The Phase 3 program builds on positive top-line results from the Company’s previously reported Phase 2 studies for INOpulse® for the treatment of fILD which showed benefits in multiple cardiopulmonary parameters, including pulmonary vascular resistance and improvement in Moderate to Vigorous Physical Activity (MVPA). If approved, INOpulse would become the first therapy to treat a broad fILD population, including patients at low-, intermediate- and high-risk pulmonary hypertension.
- IND Clearance from China NMPA: The Center for Drug Evaluation of China’s
National Medical Products Administration (NMPA) cleared the Company’s Investigational New Drug (IND) application to conduct a Phase 3 clinical trial to support the registration of INOpulse® for the treatment of fILD inChina . The study will utilize MVPA as the primary endpoint and be conducted in collaboration with Baylor BioSciences, a life sciences company dedicated to the development and commercialization of innovative medical products forGreater China .
Pulmonary Hypertension-Sarcoidosis (PH-Sarc)
Phase 2 Clinical Study: In
Corporate Update:
- License Agreement with Baylor BioSciences: On
January 4, 2023 , the Company entered into a license agreement with Baylor BioSciences, a life sciences company dedicated to the development and commercialization of innovative medical products inGreater China . Baylor received exclusive rights to develop and commercialize INOpulse® withinGreater China for diseases associated with pulmonary hypertension, including the lead indication of fibrotic interstitial lung disease (fILD), as well as PH-Sarcoidosis and PH-COPD. Under the terms of the license agreement, Bellerophon will receive a license payment of$6 million subject to taxes and closing costs. Additionally, the Company is entitled to royalties of 5% on net sales resulting from all of the licensed INOpulse® indications withinGreater China . - Registered Direct Offering: On
March 3, 2023 , Bellerophon entered into a subscription agreement with a life sciences-focused institutional investor to issue and sell in a registered direct offering, 718,474 shares of common stock at a price of$2.00 per share and 1,781,526 prefunded warrants at a price of$1.99 per pre-funded warrant for total gross proceeds of approximately$5 million , before deducting estimated offering expenses. The Company intends to use the proceeds of this$5 million offering to complete the ongoing REBUILD Phase 3 study and for working capital and general corporate purposes.
2022 Year-End Financial Results:
For the year ended
Research and development expenses for the year ended
General and administrative expenses for the year ended
Balance Sheet:
As of
About Bellerophon
Forward-looking Statements
Any statements in this press release about Bellerophon’s future expectations, plans, and prospects, including statements about the clinical development of its product candidates, regulatory actions with respect to the Company’s clinical trials and expectations regarding the sufficiency of the Company’s cash balance to fund clinical trials, operating expenses and capital expenditures, and other statements containing the words “anticipate,” “believe,” “continue,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: risks and uncertainties relating to INOpulse®, the uncertainties inherent in the initiation of future clinical trials, availability and timing of data from ongoing and future clinical trials and the results of such trials, whether preliminary or interim results from a clinical trial will be predictive of the final results of that trial or whether results of early clinical trials will be indicative of the results of later clinical trials, expectations for regulatory approvals, the FDA’s substantial discretion in the approval process, availability of funding sufficient for our foreseeable and unforeseeable operating expenses and capital expenditure requirements and other factors discussed in the “Risk Factors” section of the Company’s most recent Annual Report on Form 10-K and in subsequent filings with the
Contacts
(212) 915-2578
britchie@lifesciadvisors.com
BELLEROPHON THERAPEUTICS, INC. | ||||||||
Consolidated Balance Sheets | ||||||||
(Amounts in thousands, except share and per share data) | ||||||||
As of | As of | |||||||
Assets | ||||||||
Current assets: | ||||||||
Cash and cash equivalents | $ | 6,924 | $ | 24,736 | ||||
Restricted cash | 405 | 103 | ||||||
Prepaid expenses and other current assets | 234 | 620 | ||||||
Total current assets | 7,563 | 25,459 | ||||||
Restricted cash, non-current | — | 300 | ||||||
Right of use assets, net | 184 | 863 | ||||||
Property and equipment, net | 2 | 67 | ||||||
Other non-current assets | 186 | 186 | ||||||
Total assets | $ | 7,935 | $ | 26,875 | ||||
Liabilities and Stockholders' Equity | ||||||||
Current liabilities: | ||||||||
Accounts payable | $ | 1,230 | $ | 1,192 | ||||
Accrued research and development | 2,655 | 1,397 | ||||||
Accrued expenses | 1,313 | 1,711 | ||||||
Current portion of operating lease liabilities | 203 | 752 | ||||||
Total current liabilities | 5,401 | 5,052 | ||||||
Long term operating lease liabilities | — | 203 | ||||||
Common stock warrant liability | — | 1 | ||||||
Total liabilities | 5,401 | 5,256 | ||||||
Commitments and contingencies | ||||||||
Stockholders' equity: | ||||||||
Common stock, |
96 | 95 | ||||||
Preferred stock, |
— | — | ||||||
Additional paid-in capital | 254,516 | 253,771 | ||||||
Accumulated deficit | (252,078 | ) | (232,247 | ) | ||||
Total stockholders' equity | 2,534 | 21,619 | ||||||
Total liabilities and stockholders' equity | $ | 7,935 | $ | 26,875 |
BELLEROPHON THERAPEUTICS, INC. | |||||||
Consolidated Statements of Operations And Comprehensive Loss | |||||||
(Amounts in thousands, except share and per share data) | |||||||
2022 |
2021 |
||||||
Operating expenses: | |||||||
Research and development | $ | 16,362 | $ | 13,015 | |||
General and administrative | 6,022 | 7,146 | |||||
Total operating expenses | 22,384 | 20,161 | |||||
Loss from operations | (22,384 | ) | (20,161 | ) | |||
Change in fair value of common stock warrant liability | 1 | 600 | |||||
Interest income and financing expenses, net | 135 | 5 | |||||
Pre-tax loss | (22,248 | ) | (19,556 | ) | |||
Income tax benefit | 2,417 | 1,800 | |||||
Net loss and comprehensive loss | $ | (19,831 | ) | $ | (17,756 | ) | |
Weighted average shares outstanding: | |||||||
Basic | 9,550,872 | 9,502,793 | |||||
Diluted | 9,550,872 | 9,502,793 | |||||
Net loss per share: | |||||||
Basic | $ | (2.08 | ) | $ | (1.87 | ) | |
Diluted | $ | (2.08 | ) | $ | (1.87 | ) |

Source: Bellerophon Therapeutics, Inc.